PMID- 31456431
OWN - NLM
STAT- MEDLINE
DCOM- 20201013
LR  - 20201013
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 36
IP  - 1
DP  - 2020 Jan
TI  - Safety and tolerability of ALO-02 (oxycodone hydrochloride and sequestered 
      naltrexone hydrochloride) extended-release capsules in older patients: a pooled 
      analysis of two clinical trials.
PG  - 91-99
LID - 10.1080/03007995.2019.1661679 [doi]
AB  - Objective: To assess the impact of age on the safety and tolerability of ALO-02, 
      an abuse-deterrent opioid formulation consisting of oxycodone hydrochloride and 
      sequestered naltrexone hydrochloride, in patients with chronic pain.Methods: Data 
      from two clinical studies in patients with chronic low back pain or chronic 
      non-cancer pain were analyzed. Patients aged >/=18 years who required continuous 
      around-the-clock opioid analgesia for an extended period were grouped into 
      >/=65 years and <65 years age groups. Treatment-emergent adverse events (TEAEs), 
      use of concomitant medications, clinical laboratory measurements, and occurrences 
      of opioid withdrawal using reported adverse events (AEs) and Clinical Opiate 
      Withdrawal Scale (COWS) scores assessed safety. Data pooling was employed for the 
      titration and maintenance phases of both studies.Results: Respectively 805 and 
      436 patients received >/=1 dose of ALO-02 in the titration and maintenance phases; 
      121 (15.0%) and 83 (14.6%) patients, respectively, were aged >/=65 years in the 
      titration and maintenance phases. Average doses of ALO-02 were lower in the older 
      patients in both phases. Incidences of TEAEs were comparable between age groups 
      in both phases and generally lower in the maintenance phase. Concomitant 
      medications were taken more often by patients aged >/=65 years. Incidences of 
      potentially clinically significant laboratory results were low in both phases 
      with no clinically important differences between age groups. There were few 
      reports of opioid withdrawal events as assessed by reported AEs and COWS scores. 
      One patient aged >/=65 years experienced an AE of opioid withdrawal.Conclusions: 
      The safety and tolerability of ALO-02 is similar in those aged >/=65 years and 
      those aged <65 years with chronic pain.ClinicalTrials.gov identifiers: 
      NCT01571362, NCT01428583.
FAU - Wilson, Jacquelyn G
AU  - Wilson JG
AD  - Clinical Development and Operations, Pfizer Inc., Durham, NC, USA.
FAU - Bass, Almasa
AU  - Bass A
AD  - Pfizer Inc., Durham, NC, USA.
FAU - Pixton, Glenn C
AU  - Pixton GC
AD  - Pfizer Inc., Durham, NC, USA.
FAU - Wolfram, Gernot
AU  - Wolfram G
AD  - Pfizer Inc., Durham, NC, USA.
FAU - Rauck, Richard L
AU  - Rauck RL
AD  - Center for Clinical Research, Carolinas Pain Institute, Winston Salem, NC, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01571362
SI  - ClinicalTrials.gov/NCT01428583
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20190917
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Drug Combinations)
RN  - 0 (oxycodone naltrexone combination)
RN  - 5S6W795CQM (Naltrexone)
RN  - CD35PMG570 (Oxycodone)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics, Opioid/therapeutic use
MH  - Chronic Pain/*drug therapy
MH  - Delayed-Action Preparations
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Low Back Pain/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Naltrexone/*administration & dosage
MH  - Oxycodone/*administration & dosage
MH  - Randomized Controlled Trials as Topic
MH  - Young Adult
OTO - NOTNLM
OT  - Abuse-deterrent
OT  - chronic pain
OT  - extended release
OT  - naltrexone
OT  - opioid
OT  - oxycodone
OT  - safety
EDAT- 2019/08/29 06:00
MHDA- 2020/10/21 06:00
CRDT- 2019/08/29 06:00
PHST- 2019/08/29 06:00 [pubmed]
PHST- 2020/10/21 06:00 [medline]
PHST- 2019/08/29 06:00 [entrez]
AID - 10.1080/03007995.2019.1661679 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2020 Jan;36(1):91-99. doi: 10.1080/03007995.2019.1661679. Epub 
      2019 Sep 17.